Supplies of Epipen Jr (150mcg adrenaline) products have run out in Australia and families of children with with allergic asthma are being advised to keep their expired auto-injectors for emergency use until replacement stock becomes available in late December 2019.
Manufacturer Mylan has advised that no EpiPen Jr products are available from 5 December and the only possible replacement product in the pipeline is a contaminated batch expected to arrive from the US after 17 December.
According to the TGA the critical nature of the ongoing EpiPen Jr shortage has forced it to approve a batch that has been found to be affected by very low-level contamination with pralidoxime, the antidote for anticholinesterase poisoning such as with organophosphate insecticide compounds.
The contamination occurred during manufacturing and the TGA says the amount of pralidoxime per EpiPen Jr should not cause any adverse effects as it is less than 0.1% of the recommended therapeutic dose indicated for organophosphate poisoning in children.
“In the situations in which EpiPen Jr is used, administration of adrenaline can be life-saving. The risk from not having adrenaline available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime,” the TGA says.
“EpiPen Jr supplies are currently critically constrained in Australia and other countries. The release of the affected batch (no: 9KC652) will go some way towards meeting continuing patient demand.”
In a statement, the Australasian Society of Clinical Immunology and Allergy (ASCIA) said it was recommending that all remaining stock of EpiPen Jr in pharmacies should be provided to newly diagnosed infants and children weighing 7.5-20kg, and children who have used their EpiPenJr and have no other dose available.
Patients with an EpiPen Jr that has recently expired should keep and use this EpiPen Jr in an emergency, it advised.
“Whilst the use of an expired EpiPen Jr adrenaline autoinjector is not ideal, research suggests that recently expired devices retain potency. Therefore, if no other EpiPen Jr is available, use of a recently expired EpiPen Jr to treat anaphylaxis is advised, as stated on the ASCIA website
To ensure that people at risk of anaphylaxis have access to the treatment they may need, ASCIA recommends that supply should be restricted to patients with an EpiPen Jr prescription for a new diagnosis or where an EpiPen Jr device has recently been used and there is no other EpiPen Jr available.
Supplies of EpiPen 300mcg adrenaline (epinephrine) autoinjectors are not affected.